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Sponsored by: |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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Information provided by: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT00450164 |
Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.
Condition | Intervention | Phase |
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Gastrointestinal Hemorrhage Portal Hypertension Cirrhosis |
Procedure: esofagic varices ligation Drug: Nadolol Drug: Isosorbide mononitrate Drug: Prazosin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Secondary Prophylaxis After Variceal Bleeding: Combined Treatment With Endoscopic Ligation and Nadolol Against Nadolol Associated With Mononitrate of Isosorbide or Prazosin According to Hemodynamic Response. |
Estimated Enrollment: | 50 |
Study Start Date: | November 2000 |
Study Completion Date: | June 2004 |
The present is a prospective, randomized, open label study, in parallel groups, in which the patients with hemorrhage caused by esofagic varices will be randomized in two groups of treatment, after control of acute hemorrhage.
All the patients included will receive standard medical treatment with beta - blockers and endoscopic ligation of the esofagic varices.
The control group will be constituted by the patients assigned to receive endoscopic ligation and nadolol (N).
The experimental group will be constituted by patients assigned to receive treatment according to the hemodynamic response.
All patients included in the experimental group will receive pharmacologic treatment with nadolol combined with Isosorbide Mononitrate (MNI) or Prazosin (PZ).
In both groups it will practice a basal hepatic hemodynamic study in the 4th-5th day after their admitance (after achieve hemodynamic stability for at least 48 h and with hemorrhage controlled) and a second control hepatic hemodynamic study 3-4 weeks after the beginning of the pharmacologic treatment, once adjusted doses.
In the experimental group, the responders to N + MNI will keep on this treatment, but nonrespondent in the hemodynamic study will switch treatment to N + PZ and a third hepatic hemodynamic study will be performed 3 to 4 weeks after the dosage adjustement.
The randomization will be stratified according to the degree of hepatic failure measured by Child-Pugh classification (classes A and B versus C) The design is random to avoid bias in the selection of the patients.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Unidad de Sangrantes, HSCSP | |
Barcelona, Spain, 08025 |
Principal Investigator: | Candid - Villanueva, Dr. | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Study ID Numbers: | KT-2000 |
Study First Received: | March 20, 2007 |
Last Updated: | March 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00450164 |
Health Authority: | Spain: Ethics Committee |
Variceal bleeding Secondary profilaxis Hemodynamic Portal hypertension |
Isosorbide Liver Diseases Fibrosis Gastrointestinal Diseases Isosorbide-5-mononitrate Gastrointestinal Hemorrhage Vascular Diseases Nadolol Isosorbide Dinitrate |
Liver Cirrhosis Hypertension, Portal Hemorrhage Portal hypertension Nitric Oxide Digestive System Diseases Prazosin Neoplasm Metastasis Hypertension |
Sympatholytics Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Diuretics, Osmotic Diuretics Physiological Effects of Drugs Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Nitric Oxide Donors Neoplastic Processes Neoplasms Pathologic Processes Autonomic Agents Natriuretic Agents Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Cardiovascular Diseases Peripheral Nervous System Agents Anti-Arrhythmia Agents |